DETAILED ACTION
Response to Amendment
This action is in response to the amendment after non-final submitted 13 July 2026. Claims 1-7 and 9-20 are pending, wherein claims 2-4, 6, 7, and 9-20 are withdrawn from consideration.
Response to Arguments
Applicant’s arguments filed with respect to the rejection(s) of claim(s) 1, 5, and 8 under 35 U.S.C. 103 as being unpatentable over Shuros et al. (WO 2022/020591) in view of Scharf et al. (US Publication no. 2014/0121470) have been fully considered and are persuasive. Scharf et al., teaches that genes or genetic-agents may be delivered in conjunction with cardiac mapping or therapy. However, there is no teaching for a controller that controls agent delivery, particularly delivery in conjunction with electroporation. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Arora et al. (US Publication no. 2021/0038501) in view of Shuros et al. (WO 2022/020591 – previously cited).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arora et al. (US Publication no. 2021/0038501) in view of Shuros et al. (WO 2022/020591 – previously cited).
In regard to claim 1, Arora et al. discloses a system and method for the in-vivo delivery of agents (e.g., gene therapy agents) into cardiac tissue of a subject comprising (para 27 and 30):
a 64 pole basket catheter for performing electroporation and performing in-vivo delivery of one or more genes into a heart of a patient in conjunction with the electroporation (para 24, 27, 32, 41, and 58).
Arora et al. describe use of a basket catheter, but do not describe a basket catheter that includes a plurality of splines and a plurality of electrodes mounted to each spline in the plurality of splines; and a controller device connected to the basket catheter, wherein the controller device includes a processor configured to activate at least a subset of electrodes to perform electroporation, wherein activation of at least the subset of electrodes generates current paths between electrodes on a given spline and between electrodes on adjacent splines.
Shuros et al. disclose a system for performing integrated mapping and electroporation (para 55-56, Shuros et al. is directed to a hybrid ablation catheter 100 for electroporation and another operation mode such as mapping), the system comprising: a basket catheter (i.e., electrode assembly 220 of figure 2A construed as resembling a basket shape) that includes a plurality of splines 204 (para 76-77), and a plurality of electrodes 208 and 210 mounted to each spline 204 in the plurality of splines 204 (para 76-78); and a controller device 140 (figure 1, para 55) connected to the basket catheter 220, wherein the controller device 140 includes a processor (para 61) configured to activate at least a subset of electrodes to perform electroporation (para 58, a specific set of electrodes can be activated by the controller 140 for an operation mode, wherein a "specific set" considered synonymous with "subset"; additionally, each electrode is individually addressable, para 57), wherein activation of at least the subset of electrodes generates current paths between electrodes on a given spline and between electrodes on adjacent splines (para 60, the electroporation controller 140 is configured to model the electric fields that can be generated by the catheter 110, which often includes consideration of the physical characteristics of the electroporation ablation catheter 110 including the electrodes and spatial relationships of the electrodes on the electroporation ablation catheter 110; the "spatial relationships of electrodes" as used to generate the electric field therein is considered to comprise current paths between electrodes).
It is considered to have been obvious to one of ordinary skill in the art to employ the spline supported, selectively controlled electrode basket catheter arrangement of Shuros et al. as the multi-polar basket catheter of Arora et al. Both references employ multi-electrode cardiac electroporation catheters, and applying the known spline/electrode basket catheter of Shuros et al. would have provided a predictable configuration for positioning and selectively energizing multiple electrodes to generate and control electroporation fields across the targeted cardiac tissue while retaining the intended in-vivo gene therapy function of Arora et al. Moreover, Arora et al. expressly suggest that any suitable device commercially available may be used for electroporation which further demonstrates the obviousness of employing the catheter of Shuros et al.
Additionally, with respect to claim 1, Arora et al. teaches performing the in-vivo delivery of one or more genes into cardiac tissue in conjunction with electroporation, but does not expressly teach or disclose a controller configured to control the gene therapy. Shuros et al. teaches an electroporation system having a controller configured to control operation of the electroporation catheter, including selective activation of electrodes and control the resulting electroporation field. It is considered to have been obvious to one of ordinary skill in the art to configure the controller of the combined system to additionally control in-vivo gene delivery in conjunction with electroporation. Doing so would have predictably coordinated timing of agent delivery with the electroporation procedure, thereby facilitating delivery of genetic agent to the target cardiac tissue during the period that the tissue is subject to electroporation.
In regard to claim 5, Shuros et al. further comprises an electroporation generator 150 (para 55, pulse generator) that is in communication with the controller device 140 and connected to the basket catheter 220, wherein the controller device controls the electroporation generator to deliver voltages to the subset of electrodes (para 57, pulse generator 150 delivers electroporation energy of high voltage and short pulses).
Conclusion
In view of the new grounds of rejection, this action is made NON-FINAL.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 22 September 2026
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